The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission

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The work was supported by Fondo Nacional de Desarrollo Cientifico, Tecnologico y de Innovacion Tecnologica, FONDECYT, Peru (N084-2016) to Y. E. C.-S.; the National Institutes of Health (R01-AI87776 and D43-TW010074 to R. H. G. and D43 TW007393 to A. G. L.); and InBios International, Inc to R. H. G....

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Autores: Castro-Sesquen Y.E., Tinajeros F., Bern C., Galdos-Cardenas G., Malaga E.S., Valencia Ayala E., Hjerrild K., Clipman S.J., Lescano A.G., Bayangos T., Castillo W., Menduiña M.C., Talaat K.R., Gilman R.H., Verastegui M., Calderon M., Chávez C., Leigue J.K., Hinojosa E., Urquizu F., Gorena M., Serrudo V., Cabrera L., Romero Y.K., Chagas Working Group in Bolivia and Peru
Formato: artículo
Fecha de Publicación:2021
Institución:Consejo Nacional de Ciencia Tecnología e Innovación
Repositorio:CONCYTEC-Institucional
Lenguaje:inglés
OAI Identifier:oai:repositorio.concytec.gob.pe:20.500.12390/3063
Enlace del recurso:https://hdl.handle.net/20.500.12390/3063
https://doi.org/10.1093/cid/ciaa986
Nivel de acceso:acceso abierto
Materia:Trypanosoma cruzi
Congenital Chagas disease
Diagnostics
IgM antibodies
Shed acute-phase antigen
https://purl.org/pe-repo/ocde/ford#3.03.08
id CONC_d6488720296125a0244838bb2fe1044b
oai_identifier_str oai:repositorio.concytec.gob.pe:20.500.12390/3063
network_acronym_str CONC
network_name_str CONCYTEC-Institucional
repository_id_str 4689
dc.title.none.fl_str_mv The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
title The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
spellingShingle The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
Castro-Sesquen Y.E.
Trypanosoma cruzi
Congenital Chagas disease
Diagnostics
IgM antibodies
Shed acute-phase antigen
https://purl.org/pe-repo/ocde/ford#3.03.08
title_short The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
title_full The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
title_fullStr The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
title_full_unstemmed The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
title_sort The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission
author Castro-Sesquen Y.E.
author_facet Castro-Sesquen Y.E.
Tinajeros F.
Bern C.
Galdos-Cardenas G.
Malaga E.S.
Valencia Ayala E.
Hjerrild K.
Clipman S.J.
Lescano A.G.
Bayangos T.
Castillo W.
Menduiña M.C.
Talaat K.R.
Gilman R.H.
Verastegui M.
Calderon M.
Chávez C.
Leigue J.K.
Hinojosa E.
Urquizu F.
Gorena M.
Serrudo V.
Cabrera L.
Romero Y.K.
Chagas Working Group in Bolivia and Peru
author_role author
author2 Tinajeros F.
Bern C.
Galdos-Cardenas G.
Malaga E.S.
Valencia Ayala E.
Hjerrild K.
Clipman S.J.
Lescano A.G.
Bayangos T.
Castillo W.
Menduiña M.C.
Talaat K.R.
Gilman R.H.
Verastegui M.
Calderon M.
Chávez C.
Leigue J.K.
Hinojosa E.
Urquizu F.
Gorena M.
Serrudo V.
Cabrera L.
Romero Y.K.
Chagas Working Group in Bolivia and Peru
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Castro-Sesquen Y.E.
Tinajeros F.
Bern C.
Galdos-Cardenas G.
Malaga E.S.
Valencia Ayala E.
Hjerrild K.
Clipman S.J.
Lescano A.G.
Bayangos T.
Castillo W.
Menduiña M.C.
Talaat K.R.
Gilman R.H.
Verastegui M.
Calderon M.
Chávez C.
Leigue J.K.
Hinojosa E.
Urquizu F.
Gorena M.
Serrudo V.
Cabrera L.
Romero Y.K.
Chagas Working Group in Bolivia and Peru
dc.subject.none.fl_str_mv Trypanosoma cruzi
topic Trypanosoma cruzi
Congenital Chagas disease
Diagnostics
IgM antibodies
Shed acute-phase antigen
https://purl.org/pe-repo/ocde/ford#3.03.08
dc.subject.es_PE.fl_str_mv Congenital Chagas disease
Diagnostics
IgM antibodies
Shed acute-phase antigen
dc.subject.ocde.none.fl_str_mv https://purl.org/pe-repo/ocde/ford#3.03.08
description The work was supported by Fondo Nacional de Desarrollo Cientifico, Tecnologico y de Innovacion Tecnologica, FONDECYT, Peru (N084-2016) to Y. E. C.-S.; the National Institutes of Health (R01-AI87776 and D43-TW010074 to R. H. G. and D43 TW007393 to A. G. L.); and InBios International, Inc to R. H. G. through the Johns Hopkins Bloomberg School of Public Health.
publishDate 2021
dc.date.accessioned.none.fl_str_mv 2024-05-30T23:13:38Z
dc.date.available.none.fl_str_mv 2024-05-30T23:13:38Z
dc.date.issued.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.uri.none.fl_str_mv https://hdl.handle.net/20.500.12390/3063
dc.identifier.doi.none.fl_str_mv https://doi.org/10.1093/cid/ciaa986
dc.identifier.scopus.none.fl_str_mv 2-s2.0-85112125413
url https://hdl.handle.net/20.500.12390/3063
https://doi.org/10.1093/cid/ciaa986
identifier_str_mv 2-s2.0-85112125413
dc.language.iso.none.fl_str_mv eng
language eng
dc.relation.ispartof.none.fl_str_mv Clinical Infectious Diseases
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:CONCYTEC-Institucional
instname:Consejo Nacional de Ciencia Tecnología e Innovación
instacron:CONCYTEC
instname_str Consejo Nacional de Ciencia Tecnología e Innovación
instacron_str CONCYTEC
institution CONCYTEC
reponame_str CONCYTEC-Institucional
collection CONCYTEC-Institucional
repository.name.fl_str_mv Repositorio Institucional CONCYTEC
repository.mail.fl_str_mv repositorio@concytec.gob.pe
_version_ 1844883056260808704
spelling Publicationrp06786600rp08823600rp01178600rp08837600rp08825600rp08834600rp08835600rp08836600rp00723600rp08830600rp08840600rp08826600rp08833600rp00604600rp00731600rp08831600rp08838600rp08827600rp08824600rp08832600rp08829600rp08839600rp01174600rp08841600rp08828600Castro-Sesquen Y.E.Tinajeros F.Bern C.Galdos-Cardenas G.Malaga E.S.Valencia Ayala E.Hjerrild K.Clipman S.J.Lescano A.G.Bayangos T.Castillo W.Menduiña M.C.Talaat K.R.Gilman R.H.Verastegui M.Calderon M.Chávez C.Leigue J.K.Hinojosa E.Urquizu F.Gorena M.Serrudo V.Cabrera L.Romero Y.K.Chagas Working Group in Bolivia and Peru2024-05-30T23:13:38Z2024-05-30T23:13:38Z2021https://hdl.handle.net/20.500.12390/3063https://doi.org/10.1093/cid/ciaa9862-s2.0-85112125413The work was supported by Fondo Nacional de Desarrollo Cientifico, Tecnologico y de Innovacion Tecnologica, FONDECYT, Peru (N084-2016) to Y. E. C.-S.; the National Institutes of Health (R01-AI87776 and D43-TW010074 to R. H. G. and D43 TW007393 to A. G. L.); and InBios International, Inc to R. H. G. through the Johns Hopkins Bloomberg School of Public Health.Background: Diagnosis of congenital Chagas disease (CChD) in most endemic areas is based on low-sensitive microscopy at birth and 9-month immunoglobulin G (IgG), which has poor adherence. We aim to evaluate the accuracy of the Immunoglobulin M (IgM)-Shed Acute Phase Antigen (SAPA) test in the diagnosis of CChD at birth. Methods: Two cohort studies (training and validation cohorts) were conducted in 3 hospitals in the department of Santa Cruz, Bolivia. Pregnant women were screened for Chagas disease, and all infants born to seropositive mothers were followed for up to 9 months to diagnose CChD. A composite reference standard was used to determine congenital infection and was based on the parallel use of microscopy, quantitative polymerase chain reaction (qPCR), and IgM-trypomastigote excreted-secreted antigen (TESA) blot at birth and/or 1 month, and/or the detection of anti-Trypanosoma cruzi IgG at 6 or 9 months. The diagnostic accuracy of the IgM-SAPA test was calculated at birth against the composite reference standard. Results: Adherence to the 6- or 9-month follow-up ranged from 25.3% to 59.7%. Most cases of CChD (training and validation cohort: 76.5% and 83.7%, respectively) were detected during the first month of life using the combination of microscopy, qPCR, and/or IgM-TESA blot. Results from the validation cohort showed that when only 1 infant sample obtained at birth was evaluated, the qPCR and the IgM-SAPA test have similar accuracy (sensitivity: range, 79.1%-97.1% and 76.7%-94.3%, respectively, and specificity: 99.5% and 92.6%, respectively). Conclusions: The IgM-SAPA test has the potential to be implemented as an early diagnostic tool in areas that currently rely only on microscopy. © 2020 The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.Fondo Nacional de Desarrollo Científico y Tecnológico - FondecytengOxford University PressClinical Infectious Diseasesinfo:eu-repo/semantics/openAccessTrypanosoma cruziCongenital Chagas disease-1Diagnostics-1IgM antibodies-1Shed acute-phase antigen-1https://purl.org/pe-repo/ocde/ford#3.03.08-1The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmissioninfo:eu-repo/semantics/articlereponame:CONCYTEC-Institucionalinstname:Consejo Nacional de Ciencia Tecnología e 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15:26:19.243http://purl.org/coar/access_right/c_14cbinfo:eu-repo/semantics/closedAccessmetadata only accesshttps://repositorio.concytec.gob.peRepositorio Institucional CONCYTECrepositorio@concytec.gob.pe#PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE#<Publication xmlns="https://www.openaire.eu/cerif-profile/1.1/" id="12f84d49-a833-4d67-80a5-cb9e0ef8c27f"> <Type xmlns="https://www.openaire.eu/cerif-profile/vocab/COAR_Publication_Types">http://purl.org/coar/resource_type/c_1843</Type> <Language>eng</Language> <Title>The immunoglobulin M-Shed acute phase antigen (SAPA)-test for the early diagnosis of congenital Chagas disease in the time of the elimination goal of mother-to-child transmission</Title> <PublishedIn> <Publication> <Title>Clinical Infectious Diseases</Title> </Publication> </PublishedIn> <PublicationDate>2021</PublicationDate> <DOI>https://doi.org/10.1093/cid/ciaa986</DOI> <SCP-Number>2-s2.0-85112125413</SCP-Number> <Authors> <Author> <DisplayName>Castro-Sesquen Y.E.</DisplayName> <Person id="rp06786" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Tinajeros F.</DisplayName> <Person id="rp08823" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Bern C.</DisplayName> <Person id="rp01178" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Galdos-Cardenas G.</DisplayName> <Person id="rp08837" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Malaga E.S.</DisplayName> <Person id="rp08825" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Valencia Ayala E.</DisplayName> <Person id="rp08834" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Hjerrild K.</DisplayName> <Person id="rp08835" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Clipman S.J.</DisplayName> <Person id="rp08836" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Lescano A.G.</DisplayName> <Person id="rp00723" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Bayangos T.</DisplayName> <Person id="rp08830" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Castillo W.</DisplayName> <Person id="rp08840" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Menduiña M.C.</DisplayName> <Person id="rp08826" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Talaat K.R.</DisplayName> <Person id="rp08833" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Gilman R.H.</DisplayName> <Person id="rp00604" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Verastegui M.</DisplayName> <Person id="rp00731" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Calderon M.</DisplayName> <Person id="rp08831" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Chávez C.</DisplayName> <Person id="rp08838" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Leigue J.K.</DisplayName> <Person id="rp08827" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Hinojosa E.</DisplayName> <Person id="rp08824" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Urquizu F.</DisplayName> <Person id="rp08832" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Gorena M.</DisplayName> <Person id="rp08829" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Serrudo V.</DisplayName> <Person id="rp08839" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Cabrera L.</DisplayName> <Person id="rp01174" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Romero Y.K.</DisplayName> <Person id="rp08841" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> <Author> <DisplayName>Chagas Working Group in Bolivia and Peru</DisplayName> <Person id="rp08828" /> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> </Authors> <Editors> </Editors> <Publishers> <Publisher> <DisplayName>Oxford University Press</DisplayName> <OrgUnit /> </Publisher> </Publishers> <Keyword>Trypanosoma cruzi</Keyword> <Keyword>Congenital Chagas disease</Keyword> <Keyword>Diagnostics</Keyword> <Keyword>IgM antibodies</Keyword> <Keyword>Shed acute-phase antigen</Keyword> <Abstract>Background: Diagnosis of congenital Chagas disease (CChD) in most endemic areas is based on low-sensitive microscopy at birth and 9-month immunoglobulin G (IgG), which has poor adherence. We aim to evaluate the accuracy of the Immunoglobulin M (IgM)-Shed Acute Phase Antigen (SAPA) test in the diagnosis of CChD at birth. Methods: Two cohort studies (training and validation cohorts) were conducted in 3 hospitals in the department of Santa Cruz, Bolivia. Pregnant women were screened for Chagas disease, and all infants born to seropositive mothers were followed for up to 9 months to diagnose CChD. A composite reference standard was used to determine congenital infection and was based on the parallel use of microscopy, quantitative polymerase chain reaction (qPCR), and IgM-trypomastigote excreted-secreted antigen (TESA) blot at birth and/or 1 month, and/or the detection of anti-Trypanosoma cruzi IgG at 6 or 9 months. The diagnostic accuracy of the IgM-SAPA test was calculated at birth against the composite reference standard. Results: Adherence to the 6- or 9-month follow-up ranged from 25.3% to 59.7%. Most cases of CChD (training and validation cohort: 76.5% and 83.7%, respectively) were detected during the first month of life using the combination of microscopy, qPCR, and/or IgM-TESA blot. Results from the validation cohort showed that when only 1 infant sample obtained at birth was evaluated, the qPCR and the IgM-SAPA test have similar accuracy (sensitivity: range, 79.1%-97.1% and 76.7%-94.3%, respectively, and specificity: 99.5% and 92.6%, respectively). Conclusions: The IgM-SAPA test has the potential to be implemented as an early diagnostic tool in areas that currently rely only on microscopy. © 2020 The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.</Abstract> <Access xmlns="http://purl.org/coar/access_right" > </Access> </Publication> -1
score 13.394457
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